Hi all,
I’ve been searching for some time now (without success) for information regarding whether trial participants need to provide additional consent/re-consent in certain situations. Examples of such situations include:

- a substantial amendment to the protocol is implemented that involves an additional visit/assessment/procedure

- a participant consent to take part in a trial but is found to be ineligible at screening due a transient/reversible condition. E.g. the subject meets all other criteria but is showing early signs of a common cold infection (that will likely fully resolve within a few weeks); another example is where an inclusion criterion is a flare-up of a dermatological condition (e.g. eczema) that must be above a minimum severity score – a patient’s condition may not be sufficiently severe at one screening visit but in the subsequent weeks/months increases in severity above the minimum threshold. Should/can this participant be contacted to attend a second screening visit at a later date, and if so, should additional consent be sought given that no aspect of the trial (and therefore what the participant is consenting to) has changed since the first screening visit?

If anyone has come across such guidance/information elsewhere I’d be very grateful if you could point me in the right direction!

Many thanks